As I was pursuing my doctorate, I worked as the compliance administrator for the IRB office. My dual-role afforded me an insider’s view into the challenges student researchers face when accessing IRB related information. As the newly hired full-time research compliance manager, I continue to support students new to research. I am attending the 2018 Advancing Ethical Research Conference (AER18) to learn how other compliance administrators support new researchers and build trust between researchers and diverse communities. I am particularly interested in how other compliance administrators support intercultural communication. Read more

I was very excited to learn of the opportunity to become a member of the Blog Squad for the 2018 Advancing Ethical Research Conference (AER18). I am the Research Director for the Department of the Emergency Medicine and serve as the Vice Chair for the IRB at The Lincoln Medical Center in The Bronx, New York. Initially, I became familiar with the IRB as a Principal Investigator, when I conducted a research project to fulfil the requirement for Pediatric Emergency Medicine (PEM) fellowship training. I quickly realized that research is vitally important to for the advancement of medical science and I also understood that human subjects protections, particularly in children and other vulnerable populations, is critical. As I practiced in a neighborhood of diverse and low-income households, I appreciate the importance that subjects’ rights not be violated, and that they not be unduly coerced to participate in research. It is also important that participants enter into research studies voluntarily and with sufficient information and understanding. Read more

In April, the EPA published a proposed rule titled, Strengthening Transparency in Regulatory Science. The rule would prohibit the EPA from basing regulatory action on scientific studies for which the underlying raw data and models are not publicly available “in a manner sufficient for validation and analysis.” The due date for comments on this rule is August 16. As a nonpartisan organization dedicated to advancing the highest ethical standards in the conduct of research that advances human health and well-being, PRIM&R decided it was important to comment on this proposed rule, detailing two main concerns. First, we believe that the proposed rule arbitrarily restricts access to and use of rigorous, peer-reviewed science in environmental policymaking, to the detriment of the public’s health and trust in the regulatory process. Second, we argue that the proposed rule fails to respect the contributions of human research participants. We urge EPA to withdraw this misguided rule immediately. Read more

You are the chairperson of a central IRB overseeing a large phase 3 study. Based on an anonymous call, you determine that one of the investigators is not accepting homeless people who want to enroll in the study. Read more

In this post, I continue my closer look at a few select areas of the revised Common Rule, which was published January 18, 2017 of this year, and is scheduled to go into effect January 19, 2018.
One set of changes that has not gotten very much attention is that around the definition and categorization of “vulnerable” research subjects. In this post, I explain what those changes are and reflect a bit on their significance. Read more

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Public Responsibility in Medicine and Research (PRIM&R) advances the highest ethical standards in the conduct of biomedical, behavioral, and social science research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.